DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - WO66-G609Silver Spring, MD 20993-0002

Acuity Polymers, Inc.James BonafiniPresident & COO1667 Lake Avenue, Suite 354Rochester, NY 14615

Re: K162005Trade/Device Name: Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensRegulation Number: 21 CFR 886.5916Regulation Name: Rigid Gas Permeable Contact LensRegulatory Class: Class IIProduct Code: HQDDated: October 31, 2016Received: November 1, 2016

Dear Mr. Bonafini:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

December 8, 2016

- Mr. James BonafiniPage 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation(21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or(301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

for Malvina B. Eydelman, M.D.DirectorDivision of Ophthalmic and Ear,Nose and Throat Devices

Office of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Denise L. Hampton -S

ACUITY POLYMERS, INC. 510{k) Premarket Notification Acuity 10011'1 {hexafocon A) Rigid Gas Penneable Contact Lenses

Section 10.1: 510(k) SUMMARY

1. Date Prepared

2. Applicant's Name: and Address:

3. Contact Person:

July 11, 2016

Acuity Polymers, Inc. 1667 Lake A venue, Suite 354 Rochester, NY 14615 (585) 458-8409

James A. Bonafini, Jr. President Telephone: (585) 458-8409

51 O(k) Summary

RGP Contact Lens

E-Mail: jim.bonafini@acuitypolymers.com

4. Identification ofDevice: Common Name: Proprietary Name:

Device Classification:

Device Product Code:

Daily Wear Contact Lens Acuity 1 00™ (hexafocon A) RGP

Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II (21 CFR 886.5916)

HQD

5. Premarket Notification Number not available

6. Establishment Registration Number: 3012228452

7. Owner Operator Number: 10051193

8. Description of the New Device The Acuity I 00™ (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere • with base curves of 4.0 mm to 11.50 mm • with base curve chord of 6.0 mm to 6.5 mm • with diameter of7.0 to 21.0 mm

The lens material (hexafocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO Material and Contact Lenses (hexafocon A) described in K071043.

ACUITY POLYMERS, INC. 510(k) Premarket Notification 51 O(k) Summary Acuity 1001M (hexafocon A) Rigid Gas Penneable Contact Lenses RGP Contact Lens

These devices will not be marketed with multiple components or any required accessories.

9. Intended Use

The Acuity I 00™ (hexafocon A) Rigid Gas Permeable Contact Lens are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

10. Predicate Devices: The Acuity 1 00™ (hexafocon A) RGP contact lenses for daily wear are substantially equivalent to the Boston XO (hexafocon A) Daily Wear Contact Lens (K071043). This lens was selected because it is made from an identical material and has optics designed to address the same Indications for Use.

11. Substantial Equivalence

Substantial equivalence is based on:

For design: The predicate lenses, the Boston XO RGP lenses for daily wear, have a standard or reverse lens geometry with an anterior aspheric optic surface. The new lenses, the Acuity 1 00™ RGP lenses for daily wear have the same substantially equivalent standard or reverse geometry with an anterior optic surface design.

For material: The predicate lens materials are comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A). The new lens material also is comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A).

The new lenses in this submission therefore are substantially equivalent to the lenses cleared under K071043.

12. Non-Clinical Studies

The hexafocon A lens material manufactured by Acuity Polymers, Inc. has been tested and found to meet the biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May I994 and ISO I 0993-1 (2009) for a surface device, limited contact. The chemical, mechanical and optical characteristics of the new lens have been shown to be equivalent to the predicate lenses.

ACUITY POLYMERS, INC.

510(k) Premarket Notification

510(k) Summary

Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses RGP Contact Lens

13. Clinical Studies

Clinical studies for the Acuity 100™ (hexafocon A) material have been deemed as not necessary in

support of clearance of this premarket notification as no new or additional questions of safety or

effectiveness have been raised as a result of the preclinical testing and evaluation of the material.

14. Packaging

The primary lens container for shipping is a “Flat Pack Card” which is composed of a double

well lens case and card labeling. The lenses are shipped dry and are not be sterilized by Acuity

Polymers, Inc. prior to shipment to customers.

15. Relationship to Special Controls (Guidance)

This submission requires reliance upon a guidance document to describe the change and its

relevance to current guidance. The FDA Daily Wear Contact Lens Guidance Document, May

1994, is the relevant document to which this submission is based. Clinical performance data is

not necessary since the material and optical design of the new lenses is substantially equivalent

to the material and optical design of the predicate lenses in K071043. Both the new lenses and

the predicate lens feature identical aspheric anterior optics.

16. Manufacturing & Packaging:

Finished Product Manufacturing, Inspection, Packaging and Distribution:

Acuity Polymers, Inc. (Est. Regis: #3012228452) 1667 Lake Avenue, Suite 303

Rochester, NY 14615

(585) 458-8409

17. Action Taken to Comply with FDA Special Controls:

The submission is for a daily wear contact lens, Class II subject to Special Controls. The

Special Control is the FDA Daily Wear Contact Lens Guidance Document, May 1994 to which

this submission is applied. All testing listed in this 510(k) submission is in accordance with

that document.

ACUITY POLYMERS, INC. 51 O(k) Premarket Notification 510(k) Summary Acuity 100™ (hexafocon A) Rigid Gas Penneable Contact Lenses RGP Contact Lens

10.2: Side-by-Side Comparison

NEW LENS PREDICATE LENS

Lens Characteristics Acuity 100™ (hexafocon A) RGP Lens Boston XO (hexafocn A) RGP Lens

Manufacturer Acuity Polymers, Inc Bausch+ Lomb

Material hexafoconA hexafoconA

Production method Lathe Cut Lathe Cut

UVBiocking Yes Yes

Base Curves (varies with vault) 4.0 mm to 11.5 mm 4.0 mm to 11.5 mm

Base Curve Chord 6.0 mm to 6.5 mm 6.0 mm to 6.5 mm

Design Standard & reverse geometry with anterior Standard & reverse geometry with anterior aspheric surface aspheric surface

Diameters: 7.0-2l.Omm 7.0-21.0mm

Power Range -20.000 to +20.000 -20.000 to +20.000

Astigmatism range corrected Up to 9.000 Upto 9.000

Add Powers (for multifocal) + 1.00 0 to +4.00 0 +1.00 0 to+4.00 0 The Acuity 100™ (hexafocon A) Rigid Gas Boston XO Contact Lenses are indicated Permeable Contact Lenses are indicated for for daily wear for the correction of daily wear for the correction of refractive refractive ametropia (myopia, hyperopia, error (myopia, hyperopia, presbyopia and/or astigmatism and presbyopia) in aphakic astigmatism) in aphakic and non-aphakic and non- aphakic persons with non-persons with non-diseased eyes. The lens diseased eyes. Also, the lenses may be may be prescribed in spherical and aspheric prescribed in otherwise non-diseased eyes

Indications for Use powers ranging from -20.00 0 to +20.00 0 that require a gas permeable contact lens for daily wear. The lenses may be for the management of irregular corneal prescn"bed for daily wear in otherwise non- conditions such as keratoconus, pellucid diseased eyes that require a rigid contact marginal degeneration, or following lens for the management of irregular penetrating keratoplasty or refractive (e.g., corneal conditions such as keratoconus, LASIK) surgery. pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

Refractive Index 1.415 ±0.002 1.415

Oxygen Permeability Ill ±22 100

Specif"tc Gravity 1.27±0.02 1.27

Hardness (Shore D) 80±2 81 Modulus (MPa) 1496±200 1500

Tint Visibility Ttnts -various Visibility Tints- various O&C Green #6, O&C Violet #2, O&C O&C Green #6, O&C Violet #2, O&C Yellow#18 Yellow#18

Water Content <1% <1%

Lens Type RGP RGP

ACUITY POLYMERS, INC. 510(k) Premarket Notification 510(k) Summary Acuity 100"' {hexafocon A) Rigid Gas Penneable Contact Lenses RGP Contact Lens

10.3 Conclusions

In the evaluation ofRGP materials, various properties are measured to ascertain the material's ability to meet the intended application requirements. The properties which characterize the materials classification and use are refractive index, oxygen permeability, specific gravity, hardness, modulus and water content. Those properties are described in the above comparison table. These properties or characteristics are important to the function of the final lens and form the basis for the determination of use. These material values meet the minimum values required for use in the manufacture (lathing) of RGP lenses.

Based on the data generated from the chemicaVphysical testing (See Side by Side Comparison) of Acuity 1 00™ (hexafocon A) Rigid Gas Permeable Contact Lens, it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston XO™ (hexafocon A) Daily Wear Contact Lens.